Application 209905

Type: NDA
Sponsor: ARBOR PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EVEKEO ODT	AMPHETAMINE SULFATE	TABLET, ORALLY DISINTEGRATING;ORAL	5MG	Yes	No
002	EVEKEO ODT	AMPHETAMINE SULFATE	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	Yes	No
003	EVEKEO ODT	AMPHETAMINE SULFATE	TABLET, ORALLY DISINTEGRATING;ORAL	15MG	Yes	No
004	EVEKEO ODT	AMPHETAMINE SULFATE	TABLET, ORALLY DISINTEGRATING;ORAL	20MG	Yes	No
005	EVEKEO ODT	AMPHETAMINE SULFATE	TABLET, ORALLY DISINTEGRATING;ORAL	2.5MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N209905-001	EVEKEO ODT	AMPHETAMINE SULFATE	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30
N209905-002	EVEKEO ODT	AMPHETAMINE SULFATE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30
N209905-003	EVEKEO ODT	AMPHETAMINE SULFATE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30
N209905-004	EVEKEO ODT	AMPHETAMINE SULFATE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30
N209905-005	EVEKEO ODT	AMPHETAMINE SULFATE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-04-16

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209905-001	10441554	2037-03-10		Drug product	2019-10-15
N209905-001	11160772	2037-03-10		Drug product	2021-12-09
N209905-001	11896562	2037-03-10	U-3299		2024-02-16
N209905-002	10441554	2037-03-10		Drug product	2019-10-15
N209905-002	11160772	2037-03-10		Drug product	2021-12-09
N209905-002	11896562	2037-03-10	U-3299		2024-02-16
N209905-003	10441554	2037-03-10		Drug product	2019-10-15
N209905-003	11160772	2037-03-10		Drug product	2021-12-09
N209905-003	11896562	2037-03-10	U-3299		2024-02-16
N209905-004	10441554	2037-03-10		Drug product	2019-10-15
N209905-004	11160772	2037-03-10		Drug product	2021-12-09
N209905-004	11896562	2037-03-10	U-3299		2024-02-16
N209905-005	10441554	2037-03-10		Drug product	2021-07-07
N209905-005	11160772	2037-03-10		Drug product	2021-12-09

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 6 · 207 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209905-001	EVEKEO ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209905-002	EVEKEO ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209905-003	EVEKEO ODT	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209905-004	EVEKEO ODT	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209905-005	EVEKEO ODT	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-04-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209905-001	EVEKEO ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209905-002	EVEKEO ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209905-003	EVEKEO ODT	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209905-004	EVEKEO ODT	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209905-005	EVEKEO ODT	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-04-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209905-001	EVEKEO ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209905-002	EVEKEO ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209905-003	EVEKEO ODT	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209905-004	EVEKEO ODT	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209905-005	EVEKEO ODT	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209905-001	EVEKEO ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209905-002	EVEKEO ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209905-003	EVEKEO ODT	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209905-004	EVEKEO ODT	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209905-005	EVEKEO ODT	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209905-001	EVEKEO ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209905-002	EVEKEO ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209905-003	EVEKEO ODT	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209905-004	EVEKEO ODT	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209905-005	EVEKEO ODT	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209905-001	EVEKEO ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209905-002	EVEKEO ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209905-003	EVEKEO ODT	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209905-004	EVEKEO ODT	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209905-005	EVEKEO ODT	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209905-001	EVEKEO ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209905-002	EVEKEO ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209905-003	EVEKEO ODT	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209905-004	EVEKEO ODT	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209905-005	EVEKEO ODT	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209905-001	EVEKEO ODT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209905-002	EVEKEO ODT	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209905-003	EVEKEO ODT	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209905-004	EVEKEO ODT	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2019-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209905-005	EVEKEO ODT	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-04-16	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 16 · 608 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209905-001	10441554	2037-03-10		Drug product	2019-10-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209905-001	11160772	2037-03-10		Drug product	2021-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209905-001	11896562	2037-03-10	U-3299		2024-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209905-002	10441554	2037-03-10		Drug product	2019-10-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209905-002	11160772	2037-03-10		Drug product	2021-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209905-002	11896562	2037-03-10	U-3299		2024-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209905-003	10441554	2037-03-10		Drug product	2019-10-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209905-003	11160772	2037-03-10		Drug product	2021-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209905-003	11896562	2037-03-10	U-3299		2024-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209905-004	10441554	2037-03-10		Drug product	2019-10-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209905-004	11160772	2037-03-10		Drug product	2021-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209905-004	11896562	2037-03-10	U-3299		2024-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209905-005	10441554	2037-03-10		Drug product	2021-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209905-005	11160772	2037-03-10		Drug product	2021-12-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209905-001	10441554	2037-03-10		Drug product	2019-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209905-001	11160772	2037-03-10		Drug product	2021-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209905-001	11896562	2037-03-10	U-3299		2024-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209905-002	10441554	2037-03-10		Drug product	2019-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209905-002	11160772	2037-03-10		Drug product	2021-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209905-002	11896562	2037-03-10	U-3299		2024-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209905-003	10441554	2037-03-10		Drug product	2019-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209905-003	11160772	2037-03-10		Drug product	2021-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209905-003	11896562	2037-03-10	U-3299		2024-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209905-004	10441554	2037-03-10		Drug product	2019-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209905-004	11160772	2037-03-10		Drug product	2021-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209905-004	11896562	2037-03-10	U-3299		2024-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209905-005	10441554	2037-03-10		Drug product	2021-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209905-005	11160772	2037-03-10		Drug product	2021-12-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209905-001	10441554	2037-03-10		Drug product	2019-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209905-001	11160772	2037-03-10		Drug product	2021-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209905-001	11896562	2037-03-10	U-3299		2024-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209905-002	10441554	2037-03-10		Drug product	2019-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209905-002	11160772	2037-03-10		Drug product	2021-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209905-002	11896562	2037-03-10	U-3299		2024-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209905-003	10441554	2037-03-10		Drug product	2019-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209905-003	11160772	2037-03-10		Drug product	2021-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209905-003	11896562	2037-03-10	U-3299		2024-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209905-004	10441554	2037-03-10		Drug product	2019-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209905-004	11160772	2037-03-10		Drug product	2021-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209905-004	11896562	2037-03-10	U-3299		2024-02-16	`011fe1cb6892…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amphetamine Sulfate	AMPHETAMINE SULFATE	SpecGx LLC	00242264-40d8-4267-a91a-727a1f088616	2023-05-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: AMPHETAMINE SULFATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24338-031	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-031	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-031	Evekeo ODT	AMPHETAMINE SULFATE	Azurity Pharmaceuticals, Inc.	NDA	Current
24338-031	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-031	Evekeo ODT	AMPHETAMINE SULFATE	Azurity Pharmaceuticals, Inc.	NDA	Current
24338-031	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-033	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-033	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-033	Evekeo ODT	AMPHETAMINE SULFATE	Azurity Pharmaceuticals, Inc.	NDA	Current
24338-033	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-033	Evekeo ODT	AMPHETAMINE SULFATE	Azurity Pharmaceuticals, Inc.	NDA	Current
24338-033	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-035	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-035	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-035	Evekeo ODT	AMPHETAMINE SULFATE	Azurity Pharmaceuticals, Inc.	NDA	Current
24338-035	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-035	Evekeo ODT	AMPHETAMINE SULFATE	Azurity Pharmaceuticals, Inc.	NDA	Current
24338-035	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-037	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-037	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-037	Evekeo ODT	AMPHETAMINE SULFATE	Azurity Pharmaceuticals, Inc.	NDA	Current
24338-037	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-037	Evekeo ODT	AMPHETAMINE SULFATE	Azurity Pharmaceuticals, Inc.	NDA	Current
24338-037	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-045	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-045	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75796	SUPPL	2023-10-17
75795	SUPPL	2023-10-17
75766	SUPPL	2023-10-16
72227	SUPPL	2022-10-03
72226	SUPPL	2022-10-03
72210	SUPPL	2022-10-03
70331	SUPPL	2022-03-01
70330	SUPPL	2022-03-01
70292	SUPPL	2022-02-28
67115	SUPPL	2021-04-19
67099	SUPPL	2021-04-19
59284	ORIG	2019-07-09
57545	ORIG	2019-02-13
57390	ORIG	2019-01-31
57389	ORIG	2019-01-31